News by subject: FDA

CardiacSense Ltd., a digital...

Neurelis, Inc., announced the successful filing of its investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NRL-1049, a Rho kinase (ROCK) inhibitor with a potential treatment for people living with cerebral...

Lydus Medical is pleased to announce that the Vessealtm has received FDA clearance 510(k). The Vessealtm is a microvascular anastomosis suture deployment system, for standardized omni-vessel anastomoses, enabling simple, fast, safe, and effective...

VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery...

Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, announced today that the U.S....

BD (Becton, Dickinson and Company) , a leading global medical technology company, and CerTest Biotec have announced Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a molecular polymerase chain reaction (PCR)...

- Targeting to initiate dosing of Phase 1 clinical trial in Q1 2023 to evaluate IDE161 in patients having tumors with HRD, including BRCA1/2-mutant breast and ovarian cancer - Starting dose of IDE161 in the Phase 1 dose escalation is one-half of the...

BioArctic AB's (publ) partner Eisai announced today that under the Accelerated Approval pathway the U.S. Food and Drug Administration (FDA) has approved lecanemab-irmb[1] (Brand Name in the U.S.: LEQEMBItm) 100 mg/mL injection for intravenous use, a...

The Alzheimer's Association enthusiastically welcomes today's U.S. Food and Drug Administration (FDA) action to grant the accelerated approval of Leqembitm (lecanemab) (Eisai/Biogen) for the treatment of patients in mild cognitive impairment (MCI) or...

Today, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer's disease. Leqembi is the second of a new category of medications approved for Alzheimer's disease that...

Today's FDA approval of the monoclonal antibody lecanemab (Leqembi) for the treatment of patients with early Alzheimer's disease and confirmed amyloid plaques in the brain is an...

LEQEMBItm (lecanemab-rimb) has the potential to make a difference for people living with early Alzheimer's disease (AD), their loved ones and healthcare professionals, and was recently approved by the U.S. Food and Drug Administration (FDA) for the...

Jnana Therapeutics, a biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA)...

Biologic License Application (BLA) designated Priority Review by FDA and seeks approval for rozanolixizumab for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetycholine receptor (AChR) or anti-muscle-specific...

Prapela, Inc., announced that the U.S. Food and Drug...

SafeSource Direct, LLC, the maker of high-quality, American-made personal protective equipment (PPE), delivered 1.5 million shoe covers ahead of schedule to the Indian Health Service, an agency within the Department of Health and Human Services that...

A trial led by City of Hope, one of the largest cancer research and treatment organizations in the nation, contributed to the U.S. Food and Drug Administration's approval of mosunetuzumab (commercial name: Lunsumio), the first bispecific antibody to...

Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced that the United States Food and Drug...

iOnctura, a clinical-stage biotech developing selective cancer therapies against targets that play critical roles...

Patients at Spero Rehab are seeing tremendous progress using robotics equipment from H Robotics, a rapidly-growing robotics manufacturing company specializing in state-of-the-art rehabilitation solutions. The Central Austin location of Spero Rehab,...

Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer) today announced that on December 23, 2022, it filed an NDA Amendment with the Food and Drug Administration (FDA) for its novel mechanism antidepressant EXXUAtm (gepirone ER) for treatment of Major...

nfant®, the leading provider of FDA-cleared smart baby-feeding solutions, today unveiled nfant Thrive Breast, its highly anticipated breastfeeding technology for the connected home nursery. nfant Thrive Breast, the latest expansion of nfant's...

Tempero Bio has recently been awarded a grant expected to total $5.3 million over two years from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, to support Phase I clinical studies for the treatment of cocaine...

liberDi Ltd., a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) , announced today that it has received regulatory clearance from the United States Food and Drug Administration (FDA) for its Digital Dialysis Clinic, which...

Dr. Craig Moskowitz, a dually board-certified ophthalmologist and leading no-cut laser vision correction specialist at Moskowitz Eye Care, is commending the FDA's plan to require LASIK centers to provide warning information prior to performing the...

SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing new, microbiome-based therapeutics for the treatment of inflammatory diseases, today announced that it has received clearance of its Investigational New Drug (IND)...

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the evaluation of isoflurane via the Sedaconda ACD-S device for sedation of mechanically...

Bioretec Ltd, a pioneer in bioresorbable orthopedic implants, has finalized the supplement for market authorization request in accordance with the De Novo registration process concerning the company's RemeOstm trauma screw, and FDA (U.S. Food and...

Secure Transfusion Solutions (STS), a private life sciences company pioneering innovative methods to overcome the nation's growing blood and platelet shortage, has received approval of its first Biologics License Application (BLA) from the Center for...

Burning Rock , a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today announced that its OverCtm Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device...

Visby Medicaltm announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its Respiratory Health point of care test. The Visby Medical Respiratory Health Test is a fast, polymerase chain...

Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near vision for...

HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, today announced the clearance by the U.S. Food and Drug...

LongPath Technologies is the first emissions monitoring technology to be approved by both the Environmental Protection Agency (EPA) and the Colorado Department of Public Health & Environment (CDPHE) for use as an Alternative Approved Instrument...

Datar Cancer...

ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced today the U.S. Food and Drug Administration (FDA) 510(k) clearance of the...

FDA's recent approval for cultivated chicken from Upside Foods in the U.S. on November 16 set a positive tone for the adoption of cultivated meat and other innovative food in global markets. One month after the FDA's approval, another milestone was...

Heron Therapeutics, Inc. , a commercial-stage biotechnology company focused on improving the lives of patients by...

Hoth Therapeutics, Inc. , a patient-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for the company's HT-001 therapeutic for the treatment...

Movano Health , a purpose-driven healthcare solutions company at the intersection of medical and consumer devices, today announces its smart ring, Evie. Designed specifically for women, Evie is sleek, intelligent, and comfortable, providing users...

ZielBio, Inc., a clinical-stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative drug discovery platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan...

MindRank, an artificial intelligence (AI)-empowered drug discovery company, announces today that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for MDR-001, an oral small-molecule...

In a significant step for the advancement of human health, Congress passed the FDA Modernization Act as part of the FY2023 Omnibus Appropriations Bill. It is now being forward to President Biden's desk to be signed into law....

Today, Overhearing.com announced immediate availability of over-the-counter hearing aids, enabling Americans to alleviate mild to moderate hearing loss without the need for a prescription....

Today, the U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with...

Actinogen Medical Limited  is pleased to announce receipt today of agreement from the US Food and Drug Administration (FDA) to proceed with its six-month, Phase 2b, placebo-controlled clinical trial of Xanamem in patients with early stages of...

IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products,, today announced that the Investigational New Drug (IND) application...

Everest Medicines (HKEX 1952.HK) announced today that its licensing partner, Pfizer Inc. has received acceptance from the U.S. Food and Drug Administration (FDA) for review a New Drug Application (NDA) for etrasimod for individuals living with...

Bantam Vape, LLC, a provider of high-quality, science-based e-liquid products, announced today the acceptance of its Premarket Tobacco Product Application (PMTA) submission by the U.S. Food and Drug Administration for its non-tobacco nicotine...

Radius Health, Inc. ("Radius" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved TYMLOS® (abaloparatide), a parathyroid hormone related peptide [PTHrP(1?34)] analog, as a treatment to increase bone density...